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The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit: A study protocol for a multi-centre, stepped wedge randomized controlled trial


- candidate number25601
- NTR NumberNTR6319
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2016
- Secondary IDs2013/173 METC Arnhem-Nijmegen
- Public TitleThe impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit: A study protocol for a multi-centre, stepped wedge randomized controlled trial
- Scientific TitleThe impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit: A study protocol for a multi-centre, stepped wedge randomized controlled trial
- ACRONYMUNDERPIN-ICU
- hypothesisImplementation of standardized multi component intervention package tailored to ICU patients which focusses on reducing modifiable delirium risk factors by nursing and physical therapy interventions
- Healt Condition(s) or Problem(s) studiedDelirium
- Inclusion criteriaAdult (¡İ 18 years); surgical, medical or trauma patients; admitted to one of the participating ICUs and at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
- Exclusion criteriadelirious before ICU admission; have an ICU stay < one day; if reliable assessment for delirium is not possible due to: sustained coma during complete ICU stay; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 31-dec-2016
- planned closingdate31-dec-2019
- Target number of participants1750
- InterventionsThe UNDERPIN-ICU program consists of interventions tailored for ICU patients focusing on the modifiable delirium risk factors: visual and hearing impairment, to prevent or treat sensory deprivation and ultimately the loss of orientation; sleep deprivation, to minimize/avoid sleep deprivation; cognitive impairment to (re)orientate patients with regard to time, place and person to prevent or minimize decline; and immobility, to improve patients¡¯ functional mobility in the ICU and to stimulate patients¡¯ cognition.
- Primary outcomeThe number of delirium-coma-free days in 28 days
- Secondary outcomedelirium incidence; the number of days of survival in 28 and 90 days; delirium-related outcomes including: duration of mechanical ventilation, incidence of re-intubation, or restart of mechanical ventilation in case of tracheostomy patients, incidence of ICU re-admission, unplanned removal of tubes/catheters, and the use of physical restraints; ICU and hospital length of stay; QoL and cognitive function of ICU patients at ICU admission (baseline), and three and twelve months after ICU discharge; an exploratory subgroup analyses (e.g. based on admission type, predicted delirium risk); a process evaluation to explain the effects based on adherence to the interventions; and a cost-effectiveness analysis which will include an economic evaluation.
- TimepointsDays 0, 28, 90 and 365 after admission
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIES Paul Rood
- CONTACT for SCIENTIFIC QUERIES Paul Rood
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryBackground: Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU).
Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes. Design and setting: A multicenter stepped wedge cluster randomized controlled trial.
Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
Participants: ICU patients aged 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PREDELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
- Main changes (audit trail)
- RECORD25-nov-2016 - 26-mei-2017


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